Diabetes pill future uncertain
Source: Agencies |
July 11, 2010, Sunday
|
Print Edition
Print Edition
THE diabetes pill Avandia has come under intense scrutiny on both sides of the Atlantic, leaving the drug's future uncertain as its maker, GlaxoSmithKline Plc, battles a wave of lawsuits.
In London, the European Medicines Agency launched a review into Avandia's risks and benefits, adding to pressure on a product that faces a grilling from United States experts this week over its cardiovascular safety.
Scientists at the US Food and Drug Administration are deeply divided over Avandia's heart risks amid conflicting data, according to more than 700 pages of documents prepared for an advisory panel meeting on Tuesday and Wednesday.
The FDA and EMA will consider a range of options, including whether the medicine should be pulled from the market.
Some doctors want to keep Avandia as a possible treatment for lowering blood sugar for people who are not helped by other medicines for diabetes, a disease that causes heart problems, blindness and other complications.
But critics, including some FDA staff, say diabetics have plenty of alternatives and Avandia should be banned.
The pill was once Glaxo's second-biggest drug but sales have plunged since safety fears erupted three years ago. Revenues totalled 771 million pounds (US$1.17 billion) in 2009, equivalent to 2.7 percent of Glaxo's group sales.
The big worry for investors, though, is litigation.
Concerns about the medicine's adverse impact on the heart have triggered a slew of lawsuits in the US.
Glaxo has defended the medicine, based in part on a study that the British drugmaker said found no higher rates of heart-related hospitalizations or deaths.
In London, the European Medicines Agency launched a review into Avandia's risks and benefits, adding to pressure on a product that faces a grilling from United States experts this week over its cardiovascular safety.
Scientists at the US Food and Drug Administration are deeply divided over Avandia's heart risks amid conflicting data, according to more than 700 pages of documents prepared for an advisory panel meeting on Tuesday and Wednesday.
The FDA and EMA will consider a range of options, including whether the medicine should be pulled from the market.
Some doctors want to keep Avandia as a possible treatment for lowering blood sugar for people who are not helped by other medicines for diabetes, a disease that causes heart problems, blindness and other complications.
But critics, including some FDA staff, say diabetics have plenty of alternatives and Avandia should be banned.
The pill was once Glaxo's second-biggest drug but sales have plunged since safety fears erupted three years ago. Revenues totalled 771 million pounds (US$1.17 billion) in 2009, equivalent to 2.7 percent of Glaxo's group sales.
The big worry for investors, though, is litigation.
Concerns about the medicine's adverse impact on the heart have triggered a slew of lawsuits in the US.
Glaxo has defended the medicine, based in part on a study that the British drugmaker said found no higher rates of heart-related hospitalizations or deaths.
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